Johnson and Johnson Innovative Medicine is looking to solve the problem of ensuring patient-centric master data across R&D is accurate, complete, traceable, and accessible, enabling trusted data use in clinical development, real-world evidence generation, and regulatory submissions.
Requirements
- Deep understanding of master data management (MDM) principles and patient data domains.
- Expertise in consent and preference management processes, tools, and technologies.
- Familiarity with regulatory and compliance requirements (GDPR, HIPAA, 21 CFR Part 11).
- Knowledge of relevant standards (CDISC, HL7 FHIR, OMOP, GA4GH).
- 15+ years of experience in data management, data governance, or clinical data roles in pharma/biotech.
- 10+ years’ experience delivering master data management capabilities in pharma.
Responsibilities
- Lead the design and delivery of a forward-looking patient mastering strategy that ensures consistent, high-quality, and fit-for-purpose patient and participant data across R&D.
- Develop and maintain a unified patient master that connects patient, account, and clinical study data for seamless interoperability.
- Establish frameworks and tools for capturing, managing, and tracking patient consent, preferences, and permissions across the data lifecycle.
- Drive effective patient data stewardship practices across platforms and vendor ecosystems to ensure accuracy, completeness, and consistency.
- Define and implement data quality metrics and SLAs for patient and consent data with external partners and internal stakeholders.
- Drive adoption of controlled vocabularies, standards (e.g., CDISC, HL7 FHIR, GDPR consent models), and ontologies that enhance data integrity and interoperability.
- Work closely with Data Product Architecture, Knowledge Management, and Data Product teams to ensure patient master and consent data are embedded and utilized effectively within the broader R&D data ecosystem.
Other
- This position has a primary location of Titusville, NJ but is also open to Spring House, PA or Cambridge, MA.
- This position requires up to 25% travel.
- Strong leadership, stakeholder engagement, and change management skills.
- Strong written and verbal communication skills and tenacity to drive projects to a successful outcomes.
- Ability to partner across R&D, IT (JJT), Regulatory, and external data providers.
